AccuVu
AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 21 R/O Markers
11manufacturers in China registered for this device type
48catalogue numbers in this listing
11510(k) clearances naming this product code
23recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K112452 |
| Record published | 2016-09-16 |
| Record revised | 2018-12-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 27 °C |
| Packaging | Box of 5, box of 10 |
| Sizes | Outer diameter 1.4 to 1.8 mm; length 70 to 100 cm; catheter gauge 4 to 5 Fr; pressure 1050 psi |
| Distribution end date | 2021-03-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13709702 | Outer Diameter 1.8 mm | In distribution |
| 13709203 | Length 70 cm | In distribution |
| 13709105 | Outer Diameter 1.4 mm | In distribution |
| 13709403 | Pressure 1050 psi | In distribution |
| 13709401 | Catheter Gauge 5 Fr | In distribution |
| 13709303 | Pressure 1050 psi | In distribution |
| 13709402 | Catheter Gauge 5 Fr | In distribution |
| 13709004 | Catheter Gauge 5 Fr | In distribution |
| 13709504 | Pressure 1050 psi | In distribution |
| 13709304 | Outer Diameter 1.4 mm | In distribution |
| 13709106 | Pressure 1050 psi | In distribution |
| 13709405 | Length 70 cm | In distribution |
| 13709001 | Length 70 cm | In distribution |
| 13709902 | Catheter Gauge 4 Fr | In distribution |
| 13709506 | Catheter Gauge 4 Fr | In distribution |
| 13709002 | Catheter Gauge 5 Fr | In distribution |
| 13709604 | Catheter Gauge 4 Fr | In distribution |
| 13709705 | Outer Diameter 1.4 mm | In distribution |
| 13709805 | Length 100 cm | In distribution |
| 13709801 | Catheter Gauge 5 Fr | In distribution |
| 13709804 | Length 70 cm | In distribution |
| 13709802 | Length 70 cm | In distribution |
| 13709103 | Outer Diameter 1.8 mm | In distribution |
| 13709503 | Length 100 cm | In distribution |
| 13709602 | Outer Diameter 1.8 mm | In distribution |
| 13709704 | Catheter Gauge 4 Fr | In distribution |
| 13709204 | Pressure 1050 psi | In distribution |
| 13709404 | Pressure 1050 psi | In distribution |
| 53709005 | Outer Diameter 1.8 mm | In distribution |
| 13709003 | Catheter Gauge 5 Fr | In distribution |
| 13709301 | Length 70 cm | In distribution |
| 53709003 | Length 90 cm | In distribution |
| 13709901 | Pressure 1050 psi | In distribution |
| 13709701 | Length 70 cm | In distribution |
| 13709104 | Outer Diameter 1.8 mm | In distribution |
| 13709005 | Outer Diameter 1.4 mm | In distribution |
| 13709703 | Outer Diameter 1.8 mm | In distribution |
| 13709201 | Length 70 cm | In distribution |
| 13709302 | Pressure 1050 psi | In distribution |
| 13709202 | Catheter Gauge 5 Fr | In distribution |
| 13709006 | Catheter Gauge 4 Fr | In distribution |
| 13709502 | Outer Diameter 1.8 mm | In distribution |
| 13709601 | Pressure 1050 psi | In distribution |
| 13709501 | Pressure 1050 psi | In distribution |
| 13709803 | Catheter Gauge 5 Fr | In distribution |
| 13709101 | Catheter Gauge 5 Fr | In distribution |
| 13709102 | Pressure 1050 psi | In distribution |
| 53709021 | Pressure 1050 psi | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173762 | 2018-07-18 |
| K161596 | 2017-04-28 |
| K163141 | 2017-01-06 |
| K151724 | 2015-10-14 |
| K112452 | 2012-03-30 |
| K061733 | 2006-08-24 |
| K032376 | 2003-08-26 |
| K003901 | 2001-01-17 |
| K001578 | 2000-10-13 |
| K964033 | 1997-05-06 |
| K954423 | 1995-12-01 |
Recalls Naming This Product
21 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 450 units (45 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 785 units (157 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 1550 units (155 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 950 units (95 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 1520 units (304 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 435 units (87 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 4925 units (985 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 1030 units (206 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 80 units (16 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 210 units (42 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 615 units (123 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 320 units (64 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 65 units (13 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 220 units (44 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 4840 units (484 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 5155 units (1031 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 515 units (103 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 65 units (13 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 500 units (100 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2026-03-03 | Class II | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | 105 units (21 boxes) | |
| AngioDynamics, Inc. | 510(k) number | 2017-09-22 | Class II | Process control | Product was placed into distribution prior to completion of all required post sterilization release activities. | 28 | 2018-09-19 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-06-18 | Class II | Packaging change control | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length) | 595 boxes |
| 2024-06-18 | Class II | Packaging change control | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length) | 519 boxes |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.